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Scientific background: Prior to 1998, the only pluripotent stem cells available to researchers were derived from non-human sources. In 1998, pluripotent stem cells of human origin were derived for the first time, from both human embryos and human fetal tissue. This landmark research opened the door to new scientific studies and possible therapeutic applications.

Stem cell research in Canada: Canadians figure prominently in the field of stem cell research, from the pioneering work of J.E. Till, E.A. McCulloch, and C.P. Leblond in the 1960s that defined many of the basic concepts of stem cell biology, to the present. Canadian researchers, currently recognized as international leaders in stem cell research, have made a number of key recent discoveries. Nevertheless, they are held back from undertaking research on human pluripotent embryonic stem cells by the current absence of clear guidelines and lack of regulation in the field in Canada. To address the lack of guidelines, this document provides an interpretation of the Tri-Council Policy Statement1 (a document published in 1998 by the three federal research funding agencies to guide research on human subjects) relevant to research with human pluripotent stem cells. The second limitation on stem cell research progress in Canada, the regulatory vacuum, is currently being addressed by Health Canada, and the committee encourages the government to move forward with its regulatory agenda.

The ad hoc Working Group: In response to a growing number of inquiries from Canadian health researchers as to whether embryonic stem cell research could be funded under current CIHR policy, Dr. Alan Bernstein, President of CIHR, formed the ad hoc Working Group on Stem Cell Research. The group's purpose is to provide scientific input into issues related to funding of pluripotent stem cell research, input informed by current thinking in stem cell biology, law, ethics and policy.

Scope of the document to be presented to CIHR: The Working Group's mandate is to provide immediate guidance to CIHR on what type of experiments involving human pluripotent stem cells it should be prepared to fund, in view of both policy as laid out in the Tri-Council Policy Statement and the current regulatory situation. The Group has not attempted an in-depth analysis of ethical issues, as was done in a number of studies commissioned in the United States (National Bioethics Advisory Commission and National Institutes of Health), the United Kingdom (The Nuffield Foundation and Department of Health), and elsewhere (The European Commission - Opinion #15 and Netherlands Ministry of Health, Welfare and Sport). The Working Group has not fully explored questions relating to how the experimental procedures that CIHR considers fundable in principle can be carried out in an ethically responsible manner (see "The Ethical Issues" below). In posting this document, the Working Group seeks advice on these questions from the research community and the public.

In addition, the Working Group urges CIHR to consider these issues in greater depth as soon as possible, and to begin to update the Tri-Council Policy Statement to take account of new realities in stem cell research and genetic technologies-in effect, to make the Tri-Council Statement the "living" document it was intended to be.